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PRODUCT DETAIL

Dexmedetomidine Mylan 100 mikrogramov/ml

Code 2972D
MA number 57/0375/19-S
Product Form: con inf 25x2 ml (liek.inj.skl.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 57 - HYPNOTICA, SEDATIVA
ATC:
N NERVOUS SYSTEM
N05 PSYCHOLEPTICS
N05C HYPNOTICS AND SEDATIVES
N05CM Other hypnotics and sedatives
N05CM18 Dexmedetomidine
Shelf life: 24
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 29.11.2019
PIL: PIL_Dexmedetomidine Mylan_05.2023.pdf  
SPC: SPC_Dexmedetomidine Mylan_05.2023.pdf  
Safety feature Yes
Data update: 13.03.2023
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